Asian Myeloproliferative Neoplasm (MPN) Registry

Trial Title: Asian Myeloproliferative Neoplasm (MPN) Registry

NCT ID: NCT05882773

Condition: Myeloproliferative Neoplasm
Polycythemia Vera
Essential Thrombocythemia
Post-polycythemia Vera Myelofibrosis
Post-essential Thrombocythemia Myelofibrosis
Primary Myelofibrosis
Primary Myelofibrosis, Prefibrotic Stage
Primary Myelofibrosis, Fibrotic Stage

Conditions: Official terms:
Neoplasms
Polycythemia Vera
Primary Myelofibrosis
Myeloproliferative Disorders
Polycythemia
Thrombocytosis
Thrombocythemia, Essential

Conditions: Keywords:
Myeloproliferative neoplasm
Epidemiology
Outcome
Prognostic factors

Study type: Observational [Patient Registry]

Overall status: Recruiting

Study design:

Time perspective: Other

Summary: This is a multinational, multicenter, prospective and retrospective, observational, cohort study of patients with myeloproliferative neoplasm.

Detailed description: This is a multinational, multicenter, prospective and retrospective, observational, cohort registry of patients with MPN. The registry mainly involves study centres in Asia including but not limited to Hong Kong, Singapore, Malaysia, Taiwan, Korea and Thailand. Clinicopathologic characteristics, cytogenetic characteristics, mutational characteristics, treatment characteristics, outcomes and survivals of Asian patients MPN diagnosed between 2010-2025 will be collected to establish clinical registry. Data on the clinicopathologic characteristics, cytogenetics, mutational profile, prognostic scoring treatment characteristics, responses to treatment, outcome and survivals will be collected through routine clinic visits and/or reviewing medical records. Data will be collected at diagnosis, and approximately every 6 months thereafter (for prospective data) and at progression until death/study termination.

Criteria for eligibility:

Study pop:
Three study cohorts will be involved in the study. They are: Prospective cohort - Subjects will be enrolled in the study at their diagnosis of MPN. All data will be collected on-study prospectively. Partial prospective/retrospective cohort (partial-P/R) - Subjects will be enrolled in the study after they have been diagnosed of MPN for a period of time and still being followed up clinically (alive). Data from study enrollment forward will be collected prospectively at around 6-month intervals on-study. Data prior to study enrollment are the events of interest happened and will be collected retrospectively. Retrospective cohort - Subjects enrolled in the study after they were diagnosed of MPN and died/lost to follow. All data will be collected retrospectively.

Sampling method: Non-Probability Sample
Criteria:
Inclusion Criteria: 1. Age ≥ 18 years old at the time of diagnosis of MPN. 2. Subject was diagnosed with one of the following disorders according to the 2017 WHO classification (for patients diagnosed before 2017, the bone marrow reports will be re-evaluated according to the 2017 WHO classification): 1. Polycythaemia vera 2. Essential thrombocythemia 3. Primary myelofibrosis, pre-fibrotic/early stage 4. Primary myelofibrosis, overt fibrotic stage 5. Post-polycythaemia vera myelofibrosis 6. Post-essential thrombocythaemia myelofibrosis 7. MPN-unclassifiable 3. All subjects need to provide informed consent. Exclusion Criteria: A subject will not be eligible if he/she meets any of the following criteria: 1. Subject was diagnosed with myelodysplastic syndrome, myelodysplastic syndrome/myeloproliferative neoplasm, or chronic myeloid leukaemia BCR-ABL1 positive, under the 2017 WHO classification

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Department of Medicine, Queen Mary Hospital

Address:
City: Hong Kong
Country: Hong Kong

Status: Recruiting

Contact:
Last name: Harinder Gill, MD

Phone: +852 22554542
Email: gillhsh@hku.hk

Investigator:
Last name: Harinder Gill, MD
Email: Principal Investigator

Investigator:
Last name: Garret Leung, MD
Email: Sub-Investigator

Investigator:
Last name: Yok-lam Kwong, MD
Email: Sub-Investigator

Start date: May 2023

Completion date: December 2026

Lead sponsor:
Agency: The University of Hong Kong
Agency class: Other

Collaborator:
Agency: Novartis
Agency class: Industry

Source: The University of Hong Kong

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05882773